pharma distribution

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PIB ( Buenas prácticas de distribución ) curso por Internet

Advantages Of Online Learning


In NBScience , a few of the biggest advantages of Good Disribution Practice online education are as under:

It enhances student-to-student and faculty-to-student communication.

Students can share perspectives among themselves.

Instructors are more accessible.

Students experience a sense of equality.

It enables student-centered teaching approaches.

Different learning styles are accommodated.

Instructors can allow increased opportunity for student exploration.

There is an increase in rehearsal time thereby benefitting those who ‘learn by doing’


24/7 accessibility to GDP course materials is possible.

With continual availability of course contents, students no longer need to worry about accessing

it ‘in time’.

While traditional form of education forced physical participation, and distance Good Disribution Practice education wasn’t anything better, online learning makes it possible to altogether avoid physical attendance.

congresos médicos




Buenas prácticas de distribución (PIB) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.

During the pharmaceutical GDP certification process, our highly-qualified auditors analyze your processes and policies, along with those of your supply chain partners to ensure that you consistently deliver good quality products as intended pharmaceutical manufacturers.


A valid GDP certificate by NBScience demonstrates that your organization is committed to quality in every aspect of your service, and to being a vital partner of the healthcare supply chain. Contact us to learn more about the Good Distribution Practices certification for Pharmaceutical Industry process.



Invited Trainers:

Dr. Werner Gielsdorf, HSC- Alemania

Gerente General del proyecto TACIS de la Comisión Europea en CIS, Gerente de UNCTAD, EN ESO, TIC ,

ME, Banco Mundial, UNCTAD/OMC,

entrenador de GCP, GLP, PIB,GMP


Dra. Zadorin Eugene, Doctor, Maestría en Administración de Empresas

Asociación Biofarmacéutica Internacional,


Lehrman healthcare Council, Primeros oradores de Clinical Research LLC

Oficina, former head of consulting Group of the Department of Clinical Research

( 2006-2008 ).


The pharmaceutical industry has the responsibility not only to manufacture effective and safe products, but also to ensure that they are delivered to the patient in a safe and controlled manner. Management of the supply chain is a critical activity which requires adequately designed facilities, documentation systems and trained staff. Online GDP training course will cover the regulatory requirements developed by the EU and USA regulators as well as the WHO (World Health Organisation). Delegates attending this course will be provided with information on how to design and manage warehouses, select contractors, temperature map their warehouse, develop temperature monitoring system and manage transportation of their products. In addition guidance will be given on preparing SOPs, documentation and preparing facilities for EU/USA regulatory inspections. Interactive workshops especially designed to enable participant exchange views, share experiences with others and, our expert tutor while being guided through key aspects of pharmaceutical supply chain management.


Course will be of interest to the following industries:

Pharmaceutical/veterinary manufacturers

Biotech manufacturers

Vaccine manufacturers

Suppliers of vaccines

Healthcare providers

Supplier of services to the above industries

Hospital management


Production managers

Qualified Persons/Responsible Persons

Project Managers

Procurement Managers

Quality Assurance managers/Quality Control Managers

Supplier Auditors

Regulatory Affairs Personnel

Distribution/Transport/Logistics Managers

Professionals from Distribution and Logistics Functions

Contract Warehouse Managers

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Regulatory requirements

EU Directives

WHO Guidelines

EU Legislations on Wholesale Distribution

EU Guidelines for Wholesale Distribution Practice

Role of Qualified Person and Responsible Person



Premises and facilities

Facility design

Cleaning & ‘cleanability’

Security and product integrity

People movement

Materials movement

Product segregation

Control of contamination/cross contamination

Temperature control & Monitoring – what is required



Staff selection and qualification

GDP/GMP training

SOP Training

Training records



Quality Systems


Definitions Orders



Document control and maintenance

Document Archiving

Preparing training packages


Identifying what is required

how to develop a standard format and structure

writing SOPs

critical SOPs for a warehouse

preparing SOP training packages

Non Compliance Management

investigation of non-compliance

reporting and documentation

corrective action and preventive action planning (CAPA)

Returns Management

returns of non-defective medicinal products

security and QA decision


Emergency Planning and Recall

recall procedure

investigation and reporting

corrective action planning



facility requirement

control of product and facility contamination



Stock Management

cycle counting


embalaje & Re-labelling

facility and equipment requirements

SOPs and Documentation

staff training


Warehouse Management System

Developing specification

Vendor selection




regulatory expectations


reporting and action planning



Decision process for outsourcing

Contractor selection process

Quality/Technical agreement

Contract considerations

Audits of contractors




Modes of transportation and challenges they offer Air





Vehicle design consideration

Security issues

Temperature monitoring & control

Non compliance reporting and action planning

Cold Chain Management

Developing specification

Facility design consideration

Transport issues

Packaging options

Monitoring during storage and transport

Developing procedures

Training and control

Dealing with out of specification situations


Temperature Mapping

What to consider when mapping your warehouse/trailer

Design considerations

Developing plans

Test protocols

Identifying the risk areas

Planting the temperature monitors

Collating data and data evaluation

Reporting – developing recommendations

How to maintain the qualified status -On going maintenance


Preparing for Inspections

Developing self inspection programme

Training issues

Internal audits

Action planning Root cause analysis

Preventive action

Maintaining inspection readiness status


Inspection findings

Most recent regulatory and client inspection findings


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organización de contratos de investigación

terapia con células madre